Home › Scivita Medical Technology Co., Ltd. › 4K UHD Laparoscope
4K UHD Laparoscope
Scivita Medical Technology Co., Ltd. · Model 4K5530R · UDI-DI 06971381250237
2
510(k) clearances
17,255
Adverse events (24 deaths)
19
Recalls
151
Facilities
Description
The product is composed of eyepiece, lens body, optic fiber interface.The 4K UHD Laparoscope is intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-27 | Karl Storz Endoscopy | Inadequate reprocessing validation evidence |
| 2023-11-20 | Olympus Corporation of the Americas | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocess |
| 2023-11-20 | Olympus Corporation of the Americas | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocess |
| 2023-11-06 | Olympus Corporation of the Americas | Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual |
| 2023-10-24 | Karl Storz Endoscopy | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the pa |
| 2022-02-23 | Carefusion 2200 Inc | The finished device package did not contain the IFU. |
| 2017-02-10 | Olympus Corporation of the Americas | A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot. |
| 2015-11-17 | Olympus Corporation of the Americas | A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury. |
| 2014-07-16 | Market-Tiers Inc | Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications. |
| 2009-09-28 | Ethicon, Inc. | There is the potential for the duckbill seal to become dislodged. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.